The primary objective of the study is to characterize the clinical phenotype(s) of DUPIXENT®-associated conjunctivitis events. The secondary objectives of the study are to characterize the course of conjunctivitis events during the observation period and collect and assess data on treatment for conjunctivitis events and its effectiveness.
Study Type
OBSERVATIONAL
Enrollment
50
No investigational agents will be provided to study patients, and no specific treatment is required during the study. DUPIXENT®-treated patients will receive DUPIXENT as standard of care for the treatment of their AD, as prescribed by their physician. However, continuous treatment with dupilumab for at least 8 weeks is required as a condition for eligibility.
Regeneron Study Site
Irvine, California, United States
Regeneron Study Site
Palo Alto, California, United States
Regeneron Study Site
Pasadena, California, United States
Baseline Ophthalmologist Diagnosis
Diagnosis includes: symptoms and morphological features of conjunctivitis
Time frame: Initial Visit (Day 1)
Proportion of patients in each category of ophthalmologist diagnoses
Symptoms / Morphological features
Time frame: Initial Visit (Day 1)
Proportion of patients with symptoms
Symptoms include but are not limited to: infection, dry eye, cytological shifts, etc
Time frame: Initial Visit (Day 1) up to week 52
Proportion of patients with morphological features
Morphological features include but are not limited to: bulbar redness, limbal redness, lid redness, lid roughness, etc. and associated conditions may include blepharitis, keratitis, etc.
Time frame: Initial Visit (Day 1) up to week 52
Proportion of conjunctivitis events by severity
Severity is based on the nature of the event, intensity of signs and/or symptoms, current functional impairment, and potential long-term health hazards related to the event. 3-point scale: Mild, Moderate or Severe.
Time frame: Initial Visit (Day 1) up to week 52
Duration of conjunctivitis event(s) in patients whose conjunctivitis resolved
Time frame: Up to week 52
Proportion of patients with conjunctivitis event resolution
Time frame: Up to week 52
Proportion of patients who discontinued DUPIXENT® due to conjunctivitis events
Time frame: Up to week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Regeneron Study Site
Miami, Florida, United States
Regeneron Study Site
New Orleans, Louisiana, United States
Regeneron Study Site
Baltimore, Maryland, United States
Regeneron Study Site
Boston, Massachusetts, United States
Regeneron Study Site
Great Neck, New York, United States
Regeneron Study Site
New York, New York, United States
Regeneron Study Site
Portland, Oregon, United States
...and 5 more locations
Ophthalmologists assessment of treatment effectiveness, overall and by clinical phenotype based on a 5-point scale.
Treatment Effectiveness assessed on a 5-point scale: Poor, Fair, Good, Very Good, Excellent
Time frame: Up to week 52
Change in eosinophil counts and other cells identified by impression cytology from the conjunctival tissue
Measured by conjunctival impression sample (EyeprimTM) for cytology and RNA sequencing
Time frame: Up to week 52 or resolution